NCT04934813

Brief Summary

The aim of the present randomized controlled trial (RCT) was to evaluate the efficacy of different alveolar ridge preservation (ARP) techniques on hard tissue dimensional alterations after tooth extraction, based on clinical measurements.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 22, 2021

Completed
Last Updated

June 22, 2021

Status Verified

June 1, 2021

Enrollment Period

2.8 years

First QC Date

June 4, 2021

Last Update Submit

June 14, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Vertical dimensional alterations of the alveolar ridge, after tooth extraction.

    Assessment of the alteration of the alveolar ridge height after different alveolar ridge preservation techniques, based on clinical measurements. Clinical measurements were carried out immediately after tooth extraction and 4 months later. Distances in those clinical measurements were recorded in 0.1 mm increments, using a digital calliper (Logilink digital caliper WZ0031).

    4 months

  • Horizontal dimensional alterations of the alveolar ridge, after tooth extraction.

    Assessment of the alteration of the alveolar ridge width after different alveolar ridge preservation techniques, based on clinical measurements. Clinical measurements were carried out immediately after tooth extraction and 4 months later. Distances in those clinical measurements were recorded in 0.1 mm increments, using a digital calliper (Logilink digital caliper WZ0031).

    4 months

Study Arms (4)

Alveolar ridge preservation with particulated allograft covered with collagen sponge.

EXPERIMENTAL

Alveolar ridge preservation after tooth extraction. Freeze-dried bone allograft (FDBA) was applied in the socket immediatelly after tooth extraction and it was covered with collagen sponge (CS).

Other: Alveolar ridge preservation

Alveolar ridge preservation with particulated allograft covered with autogenous soft tissue punch

EXPERIMENTAL

Alveolar ridge preservation after tooth extraction. Freeze-dried bone allograft (FDBA) was applied in the socket immediatelly after tooth extraction and it was covered with free gingival graft (FGG).

Other: Alveolar ridge preservation

Alveolar ridge preservation with particulated xenograft covered with autogenous soft tissue punch

EXPERIMENTAL

Alveolar ridge preservation after tooth extraction. Demineralized bovine bone mineral xenograft (DBBM) was applied in the socket immediatelly after tooth extraction and it was covered with free gingival graft (FGG).

Other: Alveolar ridge preservation

Alveolar ridge preservation without bone grafting covered with socket sealing mean

EXPERIMENTAL

Alveolar ridge preservation after tooth extraction. No bone graft was applied and the socket was covered with free gingival graft (FGG).

Other: Alveolar ridge preservation

Interventions

application of different bone graft and sealing means after tooth extraction

Alveolar ridge preservation with particulated allograft covered with autogenous soft tissue punchAlveolar ridge preservation with particulated allograft covered with collagen sponge.Alveolar ridge preservation with particulated xenograft covered with autogenous soft tissue punchAlveolar ridge preservation without bone grafting covered with socket sealing mean

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • systematically healthy patients
  • non-smokers
  • no use of antibiotics for the last 3 months
  • presence of a non-restorable single-rooted tooth in the maxilla.

You may not qualify if:

  • Patients were excluded when a bony wall loss of more than 50% was verified for the socket after the extraction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National and Kapodistrian University

Athens, Attica, 11527, Greece

Location

Related Publications (1)

  • El-Sioufi I, Oikonomou I, Koletsi D, Bobetsis YA, Madianos PN, Vassilopoulos S. Clinical evaluation of different alveolar ridge preservation techniques after tooth extraction: a randomized clinical trial. Clin Oral Investig. 2023 Aug;27(8):4471-4480. doi: 10.1007/s00784-023-05068-1. Epub 2023 May 25.

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, Iosif El-Sioufi, Master of Science in Periodontology, School of Dentistry, National and Kapodistrian University of Athens

Study Record Dates

First Submitted

June 4, 2021

First Posted

June 22, 2021

Study Start

March 1, 2017

Primary Completion

December 20, 2019

Study Completion

June 25, 2020

Last Updated

June 22, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations